MAUDE Adverse Event Report: IMRIS - DEERFIELD IMAGING, INC. IMRIS HFD100 SKULL CLAMP ASSEMBLY

Model Number	HFD100
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clinical specialists visited the customer site to diagnose the issue.They observed the or staff set up and pin the patient and reported that there were no errors in how the hfd was being used.After the case, they attempted to make the device fail and could not.After a thorough examination, they found no issues.
Event or Problem Description
The hfd100 head fixation device was being utilized during a surgical case and at some point intraoperatively, the brainlab navigation became inaccurate.There was no evidence of the patient slipping in the skull pins.There were no injuries reported.

• Brand Name: IMRIS HFD100 SKULL CLAMP ASSEMBLY
• Common Device Name: SKULL CLAMP ASSEMBLY
• Manufacturer (Section D): IMRIS - DEERFIELD IMAGING, INC.; 5101 shady oak road; minnetonka MN 55343 4100
• MDR Report Key: 7289802
• Report Number: 3010326005-2018-00026
• Device Sequence Number: 11325016
• Product Code: HBL
• UDI-Device Identifier: 00857534006011
• UDI-Public: 00857534006011
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K103493
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Model Number: HFD100
• Device Catalogue Number: 113803-000
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Weight: 74